CN113993594B

CN113993594B - Tooth patch

Info

Publication number: CN113993594B
Application number: CN202080042535.9A
Authority: CN
Inventors: 筒井生; 椎叶谅太; 大桥正俊; 永田亮辅
Original assignee: Kao Corp
Current assignee: Kao Corp
Priority date: 2019-06-10
Filing date: 2020-03-11
Publication date: 2024-06-07
Anticipated expiration: 2040-03-11
Also published as: WO2020250514A1; CN113993594A; JP2020200303A; JP7319936B2; TW202045146A

Abstract

The present invention relates to a dental patch having two layers that are formed by an innermost layer of an adhesion surface and that change with time, by improving the transparency of a sheet when the patch is adhered to teeth or a peripheral portion of teeth. That is, the present invention relates to a dental patch comprising an innermost adhesive layer (X) having adhesion to teeth and solubility in water, and an outermost protective layer (Y), the innermost adhesive layer (X) containing a medicinal ingredient (xa); the outermost protective layer (Y) is a layer having lower adhesiveness to teeth and solubility to water than the innermost adhesive layer (X), contains a water-insoluble polymer (ya), and contains 1 or 2 kinds selected from propylene glycol (yb) and glycerin (xc).

Description

Tooth patch

Technical Field

The present invention relates to a dental patch.

Background

In order to maintain health, or from a cosmetic standpoint, proper care of the peripheral portions of teeth such as teeth and gums is required every day. If the care is not performed sufficiently, plaque or dirt adheres to the tooth surface and deposits on the surface to cause unwanted coloration or gum deterioration, which may cause periodontal disease or gingivitis, or may be a factor of occurrence of loosening or pain of the teeth, and may impair the aesthetic appearance.

In order to prevent or treat various symptoms associated with teeth or peripheral portions of teeth and to impart beauty, a dental patch containing a desired component has been developed, and it has been attempted to apply the patch to teeth or peripheral portions of teeth so as to cause the desired component to act for a predetermined period of time.

For example, patent document 1 discloses a dental patch having a layer (a) and a layer (B) which show different pH values when dissolved in water, and a phytic acid or the like is contained in the latter layer, and the dental patch is attached to teeth to impart a change with time to the pH environment of the tooth surface and to effectively exert the phytic acid or the like, thereby exhibiting a whitening effect on the teeth.

Patent document 2 discloses a film-like external preparation for periodontal disease, which comprises a lowermost adhesive layer and an uppermost protective layer that are directly attached to teeth and/or gums, and in which the adhesion to teeth and/or gums and the dissolution rate of saliva are different between the layers; and the following attempts were made: the external preparation as a whole has a dissolution rate such that saliva is not completely dissolved in at least 3 hours from the start of sleep to the time of sleep, and thus is intended to remain in the oral cavity for a long period of time, thereby sufficiently exhibiting the effect of the pharmaceutically effective component during sleep.

(Patent document 1) International publication No. 2014/069595

(Patent document 2) Japanese patent laid-open publication 2016-84287

Disclosure of Invention

The present invention provides a dental patch, which is formed by laminating an innermost attaching layer (X) and an outermost protecting layer (Y),

The innermost adhesive layer (X) has adhesion to teeth and solubility to water, and contains a medicinal ingredient (xa);

The outermost protective layer (Y) is a layer having lower adhesiveness to teeth and solubility to water than the innermost adhesive layer (X), contains a water-insoluble polymer (ya), contains 1 or 2 kinds selected from propylene glycol (yb) and glycerin (yc),

The present invention preferably provides a dental patch comprising an innermost adhesive layer (X) and an outermost protective layer (Y) laminated together,

The outermost protective layer (Y) is a layer having lower adhesiveness to teeth and lower solubility to water than the innermost adhesive layer (X), contains a water-insoluble polymer (ya), and contains 1 or 2 kinds selected from propylene glycol (yb) and glycerin (yc), and the mass ratio ((yb)/((yb) + (yc))) of the content of the component (yb) to the total content of the component (yb) and the component (yc) is more than 0.5.

Although the sheet described in the above patent document can provide a desired effect on teeth or peripheral portions thereof, any sheet is insufficient in transparency of the outermost layer at the time of attachment, and thus the dissolution state of the sheet or the diffusion of a desired component cannot be visually recognized, and it is difficult to determine an appropriate attachment time by visual recognition.

Accordingly, the present inventors have made various studies and as a result, have found that a dental patch having an outermost protective layer which ensures good formability and exhibits excellent transparency can be obtained by providing a structure having at least two layers, i.e., an innermost adhesive layer and an outermost protective layer which exhibit a difference in adhesion to teeth and solubility in water, and by incorporating a medicinal component in the innermost adhesive layer and at least one of a water-insoluble polymer and propylene glycol or glycerin in the outermost protective layer in order to bring about a desired effect on teeth or peripheral portions of teeth.

That is, the present invention relates to a dental patch including two layers that can visually recognize the time-varying changes of the innermost layer constituting an attachment surface by improving the transparency of the outermost layer when attached to a tooth or a peripheral portion of the tooth.

According to the dental patch of the present invention, the outermost protective layer having high transparency is covered and protected when the patch is applied to a tooth or a peripheral portion of a tooth, so that the change with time, such as the transfer and diffusion of a medicinal component to the tooth or the peripheral portion of a tooth, in a layer further inside than the outermost protective layer can be visually recognized through the outermost protective layer, and the required application time can be properly clarified. The dental patch of the present invention can be visually assimilated with the teeth or the peripheral portions of the teeth, and foreign body sensation can be reduced.

Detailed Description

The present invention will be described in detail below.

The dental patch of the present invention is configured by a structure comprising at least two layers including an innermost adhesive layer (X) and an outermost protective layer (Y) having high transparency, and is used by attaching the innermost adhesive layer (X) to teeth or the peripheral portion of teeth. As described above, the innermost layer (X) of the dental patch of the present invention can be dissolved well in saliva and can appropriately exert specific actions when the dental patch is applied to teeth or peripheral portions of teeth.

Specifically, the innermost adhesive layer (X) adheres well to the teeth or the peripheral portions of the teeth, dissolves in saliva before the outermost protective layer (Y), and causes the contained medicinal component (xa) to act on the teeth or the peripheral portions of the teeth from one side. Meanwhile, the outermost protective layer (Y) does not excessively adhere to the teeth or the peripheral portions of the teeth and the like in the oral cavity as compared with the innermost adhesive layer (X), and the dissolution of saliva by the outermost protective layer (Y) is delayed as compared with the innermost adhesive layer (X), so that the dissolution of saliva by the innermost adhesive layer (X) is not unnecessarily hindered by saliva or the tongue, and the transfer and diffusion of the medicinal component (xa) to the teeth or the peripheral portions of the teeth can be promoted and such a change with time can be visually recognized through the outermost protective layer (Y).

The tooth peripheral portion refers to an oral cavity organ located in the periphery of the tooth, including gums and gums, and the dental patch of the present invention is a sheet material that is used by being attached to only the tooth, to only the tooth peripheral portion, or to both the tooth and the tooth peripheral portion. Hereinafter, the "tooth or tooth peripheral portion" is collectively referred to as "tooth or the like".

The mass of each of the dental patches of the present invention is a dry mass (dry mass) except for the stock solution used for producing the dental patch.

The innermost layer (X) of the dental patch of the present invention is a layer having adhesion to teeth and solubility to water, and containing a medicinal component (xa), and is a layer having a surface to be directly attached to teeth or the like when the dental patch of the present invention is used. Thus, when the dental patch of the present invention is applied to teeth or the like, the innermost layer (X) adheres well to teeth or the like and dissolves gradually in saliva, so that the medicinal component (xa) is transferred and diffused from the inside of the innermost layer (X) to teeth or the like, and a desired effect can be imparted to a desired site.

The pharmaceutical ingredient (xa) contained in the innermost adhesive layer (X) includes: effective components for preventing or treating periodontal disease or gingivitis, effective components for preventing dental caries, or whitening components. Specifically, there may be mentioned: is selected from 1 or more than 2 of phytic acid, pyrophosphoric acid, tripolyphosphoric acid, glycyrrhizic acid, glycyrrhetinic acid and salts thereof, potassium nitrate and fluorine. Among them, from the viewpoint of a technique in which it is desired to intensively act the medicinal ingredient on the tooth surface, it is more preferable to use phytic acid or its salt, potassium nitrate, and fluoride. Preferred fluoride compounds include fluoride ion-supplying compounds such as sodium fluoride, potassium fluoride, and ammonium fluoride, and sodium monofluorophosphate. In particular, from the viewpoint of a technique for easily beautifying teeth, it is more preferable to use phytic acid or a salt thereof.

The content of the pharmaceutical ingredient (xa) is preferably 0.05 mass% or more, more preferably 0.07 mass% or more, and still more preferably 0.1 mass% or more in 100 mass% of the innermost layer (X) from the viewpoint of effectively imparting an effect on teeth and the like. In order to ensure good permeability to teeth and the like, the content of the pharmaceutical ingredient (xa) is preferably 30 mass% or less, more preferably 20 mass% or less, and still more preferably 15 mass% or less in 100 mass% of the innermost adhesive layer (X).

More specifically, from the viewpoint of guiding to a good state by acting on teeth or the like, the content of the pharmaceutical ingredient (xa) is preferably in the following range. When the pharmaceutical ingredient (xa) is phytic acid or a salt thereof, the content of the ingredient (xa) is preferably 1 to 30% by mass, more preferably 5 to 20% by mass, and still more preferably 10 to 15% by mass in terms of the acid in 100% by mass of the innermost adhesive layer (X).

In order to ensure good solubility in saliva, to improve transparency of not only the outermost protective layer (Y) but also the innermost adhesive layer (X), and to impart high transparency to the entire dental patch, and to further enhance visualization of dissolution and diffusion of the component (xa) into teeth and the like, the innermost adhesive layer (X) preferably further contains a nonionic surfactant (xb). The nonionic surfactant (xb) preferably contains any one of polyoxyethylene hydrogenated castor oil (xb-1) and polyglycerin fatty acid ester (xb-2), and more preferably contains both polyoxyethylene hydrogenated castor oil (xb-1) and polyglycerin fatty acid ester (xb-2).

The polyoxyethylene hydrogenated castor oil (xb-1) is preferably one having an average number of moles of ethyleneoxy groups added of 20 to 60, more preferably 40 to 60, from the viewpoint of securing adhesion to teeth and further improving the transparency of the innermost adhesive layer (X).

The polyglycerin fatty acid ester (xb-2) is preferably a fatty acid derived from a C10-16 fatty acid, more preferably a C12-14 fatty acid, from the viewpoint of securing good solubility in saliva and further improving transparency of the innermost layer (X). In the same manner as described above, the average condensation degree of glycerin is preferably 5 to 12.

In terms of securing adhesiveness to teeth and solubility to saliva and further improving transparency of the innermost adhesive layer (X), the mass ratio ((xb-1)/(xb-2)) of the content of polyoxyethylene hydrogenated castor oil (xb-1) to the content of polyglycerin fatty acid ester (xb-2) in the innermost adhesive layer (X) is preferably 0.1 or more, more preferably 0.5 or more, further preferably 1 or more, and preferably 10 or less, more preferably 9 or less, further preferably 7 or less.

The innermost layer (X) may contain a nonionic surfactant other than the polyoxyethylene hydrogenated castor oil (xb-1) and the polyglycerin fatty acid ester (xb-2) as the nonionic surfactant (xb). The nonionic surfactant may be 1 or 2 or more selected from polyoxyethylene alkyl ether, polyoxyethylene polyoxypropylene copolymer, sucrose fatty acid ester, sorbitan fatty acid ester, glycerin fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene sorbitol fatty acid ester, polyoxyethylene glycerin fatty acid ester, polyoxyethylene glycol fatty acid ester, polyoxyethylene phytosterol and phytostanol, polyoxyethylene lanolin and lanolin alcohol, polyoxyethylene alkylamine and fatty acid amide, polyoxyethylene alkylphenyl formaldehyde condensate, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene alkylphenyl ether and fatty acid ethanolamide. Among them, 1 or 2 kinds selected from sucrose fatty acid esters and polyoxyethylene sorbitan fatty acid esters are preferable.

The total content of the nonionic surfactant (xb) including the polyoxyethylene hydrogenated castor oil (xb-1) and the polyglycerin fatty acid ester (xb-2) is preferably 0.8 mass% or more, preferably 2 mass% or more, more preferably 3 mass% or more, further preferably 4 mass% or more, and preferably 6 mass% or less, more preferably 5 mass% or less, further preferably 4.7 mass% or less, of 100 mass% of the innermost adherent layer (X), in terms of maintaining the adhesiveness to teeth and the solubility to saliva of the innermost adherent layer (X) well and further improving the transparency of the innermost adherent layer (X).

In the same manner as described above, the content of the polyoxyethylene hydrogenated castor oil (xb-1) is preferably 0.2 to 5.5% by mass, more preferably 0.6 to 4.5% by mass, and still more preferably 1.5 to 3.5% by mass, based on 100% by mass of the innermost adhesive layer (X).

Further, from the same viewpoints as described above, the content of the polyglycerin fatty acid ester (xb-2) is preferably 0.1 to 3% by mass, more preferably 0.2 to 2.2% by mass, and still more preferably 0.5 to 2% by mass, in 100% by mass of the innermost adhesive layer (X).

The innermost attachment layer (X) may further contain a perfume (xc). Examples of the perfume (xc) include: single fragrance ingredients such as menthol, pulegol (pulegol), carvone, anethole, eucalyptol, methyl salicylate, cinnamaldehyde, eugenol, 3-1-menthoxypropane-1, 2-diol, daphnol, citronellyl acetate, linalool, linalyl acetate, geraniol, geranyl acetate, citronellol, limonene, menthone, menthyl acetate, N-substituted-p-menthane-3-carboxamide, pinene, octanal, citral, pulegone (pulegone), carvyl acetate, dihydrocarvoyl acetate, anisaldehyde, benzaldehyde, camphor, lactone, ethyl acetate, ethyl butyrate, allyl cyclohexyl propionate, methyl anthranilate, ethyl methyl phenyl glycidate, vanillin, undecalactone, hexanal, butyl acetate, isoamyl acetate, hexenol, dimethyl sulfide, methyl cyclopentenone (cycloene), furfural, trimethyl pyrazine, ethyl lactate, methyl lactate, ethyl thioacetate; blended spice components such as strawberry spice, apple spice, banana spice, pineapple spice, grape spice, mango spice, butter spice, milk spice, fruit mixed spice, and tropical fruit spice; peppermint oil, spearmint oil, cassiterite oil, anise oil, eucalyptus oil, wintergreen oil, cinnamon oil, clove oil, thyme oil, sage oil, nutmeg oil, fennel oil, lemon oil, orange oil, peppermint oil, cardamon oil, coriander seed oil, basil oil, tangerine oil, lime oil, lavender oil, rosemary oil, ginger oil, grapefruit oil, bay oil, golden chrysanthemum oil, caraway oil, marjoram oil, bay oil, lemon grass oil, lemon balm oil, multi-spice oil, rose oil, rosewood oil, pine needle oil, bitter orange leaf oil, orange flower oil, rose oil, jasmine oil and the like, and spice components obtained by processing these natural spice components.

The content of the component (xc) is preferably 0.1 to 3 mass%, more preferably 0.2 to 2 mass%, and even more preferably 0.3 to 1 mass% in 100 mass% of the innermost adhesive layer (X) in terms of providing a good flavor and masking the odor of the component (xa) to reduce the uncomfortable feeling upon adhesion.

The innermost adhesive layer (X) preferably contains a water-soluble polymer (xd) from the viewpoint of ensuring good formability of the innermost adhesive layer (X) itself and from the viewpoint of promoting the transfer and diffusion of the component (xa) to teeth and the like. Here, water-soluble means that 0.1g or more of the component is dissolved in 100g of water at 25 ℃.

Specific examples of the water-soluble polymer (xd) include: 1 or more than 2 kinds selected from pullulan, hydroxyethyl cellulose, guar gum, hydroxypropyl cellulose, hypromellose, gelatin and agar. Among them, 1 or 2 kinds selected from pullulan, agar and hypromellose are preferable from the viewpoint of improving the transparency of the innermost adhesive layer (X) and visualizing the transmission and diffusion of the component (xa) to teeth and the like.

Regarding the content of the water-soluble polymer (xd), the content of the water-soluble polymer (xd) is preferably 30 to 70 mass%, more preferably 40 to 65 mass%, and even more preferably 45 to 60 mass% in 100 mass% of the innermost adhesive layer (X) from the viewpoints of ensuring good formability of the innermost adhesive layer (X) itself and promoting the transfer and diffusion of the component (xa) to teeth and the like.

The innermost layer (X) may contain, in addition to the above-mentioned components, for example, a pH adjuster such as sodium hydroxide or potassium hydroxide, a wetting agent such as propylene glycol or glycerin, a sweetener such as saccharin sodium or sucralose, a preservative, a coloring matter, and the like as components other than the above-mentioned components within a range that does not impair the effects of the present invention. Among them, if potassium hydroxide is used as the pH adjuster, it is also useful to improve the solubility or dispersibility of the contained component in the dental patch.

Further, when the dental patch of the present invention is used, it is preferable to maintain a proper water content in the innermost adhesive layer (X) after the drying step in the production process, from the viewpoint of maintaining good adhesion and flexibility and ensuring solubility and dispersibility of the contained components in the dental patch. The water content is preferably 5 to 16 mass%, more preferably 6 to 15 mass%, and even more preferably 7 to 14 mass% in 100 mass% of the innermost adhesive layer (X).

The outermost protective layer (Y) of the dental patch of the present invention is a layer having lower adhesiveness to teeth and solubility to water than the innermost adhesive layer (X), contains a water-insoluble polymer (ya), and contains 1 or 2 kinds selected from propylene glycol (yb) and glycerin (yc). Thus, adhesion to teeth and solubility to saliva can be made lower than those of the innermost adhesive layer (X), and formability of the outermost protective layer (Y) can be improved to impart excellent transparency. Therefore, when the dental patch of the present invention is applied to teeth or the like, the outermost protective layer (Y) having a solubility in saliva lower than that of the innermost adhesive layer (X) can cover and protect the innermost adhesive layer (X) which is dissolved in saliva first, and changes with time such as transmission and diffusion of the medicinal component (xa) in the innermost adhesive layer (X) to teeth or the like can be visually recognized through the outermost protective layer (Y). The outermost protective layer (Y) can be easily removed by brushing with a toothbrush after the medicinal component (xa) has been activated.

Here, water-insoluble means an ingredient which dissolves in 100g of water at 25℃in an amount of less than 0.1 g.

In the outermost protective layer (Y), the content of the surfactant is preferably less than 0.1 mass% in 100 mass% of the outermost protective layer (Y), more preferably less than 0.01 mass%, and particularly preferably the outermost protective layer (Y) contains no surfactant, from the viewpoint of effectively suppressing the occurrence of fish eye cracks and the like and imparting excellent transparency.

The water-insoluble polymer (ya) may be 1 or 2 or more selected from ethyl cellulose, hydroxypropyl methylcellulose acetate succinate, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, shellac, polyvinyl acetate, polymethyl methacrylate, methacryloyl ethyl betaine/methacrylate copolymer, methacrylic acid copolymer, aminoalkyl methacrylate copolymer, and agar. Among them, from the viewpoint of preventing occurrence of clouding in the outermost protective layer (Y) and imparting excellent transparency, 1 or 2 kinds selected from ethyl cellulose and shellac are preferable, and ethyl cellulose is more preferable.

In terms of effectively suppressing occurrence of fish-eye cracks and the like in the outermost protective layer (Y) and imparting excellent transparency, the mass ratio (((yb) + (yc))/(ya)) of the content of propylene glycol (yb) and glycerin (yc) to the content of the water-insoluble polymer (ya), that is, the mass ratio (((yb) + (yc))/(ya)) of the total content of the component (yb) and the component (yc) to the content of the component (ya) is preferably 0.1 or more, more preferably 0.25 or more, still more preferably 0.43 or more, preferably 9 or less, still more preferably 4 or less, and further preferably 2.3 or less. The mass ratio of the total content of the component (yb) and the component (yc) to the content of the component (ya) ((yb) + (yc))/(ya)) is preferably 0.1 to 9, more preferably 0.25 to 4, and still more preferably 0.43 to 2.3. The mass ratio ((yb)/(ya)) of the content of propylene glycol (yb) to the content of the water-insoluble polymer (ya) is preferably 0.1 to 9, more preferably 0.25 to 4, and still more preferably 0.43 to 2.3.

The mass ratio ((yb)/((yb) + (yc)))) of the content of propylene glycol (yb) to the total content of propylene glycol (yb) and glycerin (yc) is more than 0.5, preferably more than 0.7, and more preferably more than 0.9. The upper limit value of the mass ratio (yb)/((yb) + (yc)) may be 1 or less.

In terms of ensuring good formability of the outermost protective layer (Y) and disintegration properties by brushing as well, the total content of 1 or 2 or more selected from the components (yb) and (yc) is preferably 7 mass% or more, more preferably 20 mass% or more, still more preferably 40 mass% or more, and preferably 90 mass% or less, more preferably 80 mass% or less, still more preferably 70 mass% or less, of 100 mass% of the outermost protective layer (Y).

The outermost protective layer (Y) may contain, for example, a preservative, a coloring agent, or the like as a component other than the above components within a range that does not impair the effects of the present invention.

The thickness of the outermost protective layer (Y) is preferably 0.1 μm or more, more preferably 0.2 μm or more, and still more preferably 0.3 μm or more, from the viewpoint of effectively preventing the dissolution of saliva by the innermost adhesive layer (X) by saliva or tongue, promoting the dissolution of saliva by the innermost adhesive layer (X), and the good transfer and diffusion of the medicinal ingredient (xa) to teeth or the like. In addition, from the viewpoint of ensuring high transparency of the outermost protective layer (Y) and the viewpoint of preventing discomfort even when the outermost protective layer (Y) is closed during attachment, the thickness of the outermost protective layer (Y) is preferably 5 μm or less, more preferably 3 μm or less, and still more preferably 2.5 μm or less. The thickness of the outermost protective layer (Y) is preferably 0.1 to 5. Mu.m, more preferably 0.2 to 3. Mu.m, and still more preferably 0.3 to 2.5. Mu.m.

The thickness of the innermost layer (X) is preferably 9.9 to 95 μm, more preferably 19.8 to 87 μm, and even more preferably 29.7 to 77.5 μm or less, from the viewpoint of being effectively covered and protected by the outermost protective layer (Y) during good transfer and diffusion of the medicinal ingredient (xa) to teeth and the like, and from the viewpoint of being completely dissolved in saliva in a proper time.

The dental patch of the present invention may further comprise an intermediate layer (Z) formed between the innermost adhesive layer (X) and the outermost protective layer (Y), in addition to the innermost adhesive layer (X) and the outermost protective layer (Y). Thus, when in use, the innermost layer (X) dissolves in saliva to release the pharmaceutical ingredient (xa) into the oral cavity, and then the intermediate layer (Z) dissolves in saliva to release the pharmaceutical ingredient (xa-2) into the oral cavity. (xa-2) is a component different from the pharmaceutical component (xa) contained in the innermost layer (X), and is exemplified by 1 or 2 or more selected from phytic acid, pyrophosphoric acid, triphosphoric acid, glycyrrhizic acid, glycyrrhetinic acid, salts thereof, potassium nitrate and fluorine. By providing the intermediate layer (Z), it is easy to impart stepwise solubility, that is, to dissolve the intermediate layer (Z) after dissolving the innermost adhesive layer (X).

The material of the intermediate layer (Z) may be 1 or 2 or more selected from pullulan, hydroxyethyl cellulose, guar gum, hydroxypropyl cellulose, hypromellose, gelatin, and agar.

The total thickness of the dental patch of the present invention is preferably 100 to 10 μm, more preferably 90 to 20 μm, and still more preferably 80 to 30 μm or less, from the viewpoints of ensuring flexibility suitable for adhesion or following property to teeth or the like, and ensuring an amount required for a medicinal component (xa) to act on teeth or the like and guide to a good state.

In order to manufacture the dental patch of the present invention, a sheet composed of a single layer of the innermost adhesive layer (X), a sheet composed of a single layer of the outermost protective layer (Y), and a sheet composed of a single layer of the optional intermediate layer (Z) may be formed separately, and then laminated, or may be laminated in order on a base material. The dental patch of the present invention can be formed by using a stock solution (X) for the innermost adhesive layer (X), using a stock solution (Y) for the outermost protective layer (Y), using a stock solution for the intermediate layer (Z) as well, forming the stock solutions into layers, and then drying the layers.

The stock solution (X) for forming the innermost layer (X) may be prepared by appropriately containing the pharmaceutical ingredient (xa) in the above-described specific amount and water or other ingredients, and the stock solution (Y) for forming the outermost protective layer (Y) may be prepared by appropriately containing the water-insoluble polymer (ya) and propylene glycol (yb) in the above-described specific mass ratio and water or other ingredients. The stock solution for forming the intermediate layer (Z) may be prepared in the same manner.

Specifically, for example, in the case of forming a sheet composed of a single layer of the innermost adhesive layer (X), after preparing the stock solution (X) containing the pharmaceutical ingredient (xa), the stock solution (X) is applied to a polyethylene terephthalate (PET) film subjected to a mold release treatment or the like while taking the thickness into consideration, and dried. Then, by peeling the PET film, sheets each composed of a single layer can be obtained. The sheet constituting the surface to be attached to the teeth or the like may be directly carried without peeling the PET film. Then, a PET film is disposed on the lowermost layer, and an innermost layer (X) composed of a single layer constituting a surface to be attached to teeth or the like, another intermediate layer (Z), and a sheet composed of a single layer corresponding to the outermost protective layer (Y) are sequentially laminated thereon, and then, for example, pressure bonding is performed using a pressurizing device. Furthermore, the pressurizing device can also be heated here. Thereafter, the lowermost PET film is peeled off to obtain the dental patch of the present invention.

When the innermost adhesive layer (X) is formed on a surface to be adhered to a tooth or the like in the case of sequentially laminating the PET film on a base material, for example, the base material is first coated with the stock solution (X) and dried to form the innermost adhesive layer (X). Next, after optionally forming an intermediate layer (Z) on the innermost adhesive layer (X), the raw liquid (Y) is applied and dried to form an outermost protective layer (Y), whereby the dental patch of the present invention can also be obtained.

The dental patch of the present invention can bring about a desired effect derived from the medicinal ingredient (xa) to the teeth or the like of an adherend by attaching to the teeth or the like. In the case of applying the dental patch to teeth or the like, the time from immediately after the application to the time when the innermost adhesive layer (X) is completely dissolved in saliva is preferably 3 minutes or more, more preferably 5 minutes or more, further preferably 7 minutes or more, and preferably 60 minutes or less, more preferably 45 minutes or less, further preferably 30 minutes or less.

The dental patch of the present invention is formed by coating an innermost adhesive layer (X) constituting an adhesive surface to be applied to teeth or the like with an outermost protective layer (Y) having high transparency. Therefore, the dissolution state of the layer disposed further inside than the outermost protective layer (Y) or the transmission and diffusion state of the medicinal ingredient (xa) to the teeth and the like can be visually recognized through the outermost protective layer (Y) at the site where the sheet is attached, and the appropriate attachment time can be properly clarified. Further, by applying a color or a pattern to a layer disposed further inside than the outermost protective layer (Y), the change with time can be easily visually recognized through such an outermost protective layer (Y). Further, if the transparency of the innermost adhesive layer (X) is also improved, the dental patch of the present invention can be visually assimilated with the teeth or the peripheral portions of the teeth, and foreign body sensation can be reduced.

Examples (example)

The present invention will be specifically described below based on examples. Unless otherwise indicated, the contents of the respective components are represented by mass%.

Examples 1 to 21 and comparative examples 1 to 2

In order to obtain the innermost adherent layer (X) shown in table 1, a stock solution (X) was prepared using purified water as a solvent and mixing the components containing phytic acid as the medicinal component (xa). Similarly, in order to obtain the outermost protective layer (Y) shown in table 1, a stock solution (Y) was prepared by using ethanol as a solvent and mixing a water-insoluble polymer (ya) and propylene glycol (yb) or glycerin (yc).

Then, the obtained dope (X) was coated on a polyethylene terephthalate (PET) film while taking the thickness into consideration, and dried to obtain an innermost adhesive layer (X). Then, the stock solution (Y) is applied from the innermost adhesive layer (X) and dried to obtain a dental patch having a total thickness of 61 to 72 μm, which is obtained by laminating the outermost protective layer (Y) on the innermost adhesive layer (X) in a thickness of 60 to 70. Mu.m, in a thickness of 1 to 2. Mu.m.

The values shown in table 1 are values of the innermost layer (X) and the outermost protective layer (Y) constituting the dried dental patch.

Evaluation of transparency of outermost protective layer (Y) and transparency of the entire dental Patch

Regarding the transparency of the outermost protective layer (Y), the presence or absence of cloudiness in the outermost protective layer (Y) was used as an index for evaluation. Specifically, the obtained dental patch was placed on a black paper, and the presence or absence of cloudiness was determined by visual observation and evaluation in the following 5 stages.

The results are shown in Table 1.

1: No white turbidity is generated at all, so that the black can be immediately recognized

2: No white turbidity (no white turbidity region) and black color can be recognized

3: Although there is a little white turbidity (about 1/4 or less), black can be recognized

4: The presence of a relatively white turbidity (approximately 1/2) makes it impossible to recognize a part of black

5: The clouded portion is present throughout (approximately 3/4 or more), and black cannot be recognized

The transparency of the entire dental patch was evaluated as an index of whether or not characters could be recognized through the sheet. Specifically, the dental patch is disposed at a predetermined distance from the paper on which the letters are printed, and whether or not the letters can be recognized by visual inspection through the sheet is determined based on the following determination criteria.

The results are shown in Table 2.

1: Since it is transparent, the characters can be recognized immediately

2: Although the transparency is slightly low, the characters can be sufficiently recognized

3: Transparency is somewhat low, but characters can be barely recognized

4: The transparency is quite poor, and the characters can be barely identified

5: The transparency is completely lacking, and the characters are difficult to identify

TABLE 2

/>

Claims

1. A patch for teeth, wherein,

The dental patch is formed by laminating an innermost adhesive layer (X) and an outermost protective layer (Y),

the outermost protective layer (Y) is a layer having lower adhesiveness to teeth and solubility to water than the innermost adhesive layer (X), contains a water-insoluble polymer (ya), contains 1 or 2 kinds selected from propylene glycol (yb) and glycerin (yc), and exhibits transparency,

The component (ya) is at least 1 or 2 selected from ethyl cellulose, hydroxypropyl methylcellulose acetate succinate, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, shellac, polyvinyl acetate, polymethyl methacrylate, methacryloylethyl betaine/methacrylate copolymer, methacrylic acid copolymer, aminoalkyl methacrylate copolymer and agar, and

The total content of the component (yb) and the component (yc) and the mass ratio of the content of the component (ya) ((yb) + (yc))/(ya) is 0.1 to 9, and

The mass ratio (yb)/((yb) + (yc)) of the content of the component (yb) to the total content of the component (yb) and the component (yc) is more than 0.9.

2. The dental patch of claim 1, wherein,

The innermost adhesion layer (X) further contains a nonionic surfactant (xb), and

The content of the component (xb) in 100 mass% of the innermost adhesive layer (X) is 2 mass% or more and 6 mass% or less.

3. The dental patch of claim 2, wherein,

The component (xb) contains any 1 of polyoxyethylene hydrogenated castor oil (xb-1) and polyglycerin fatty acid ester (xb-2).

4. The dental patch of claim 2, wherein,

The component (xb) contains both polyoxyethylene hydrogenated castor oil (xb-1) and polyglycerin fatty acid ester (xb-2).

5. The dental patch of claim 3, wherein,

The average molar number of addition of vinyloxy groups in component (xb-1) is 20 to 60.

6. The dental patch according to claim 3 to 5,

Component (xb-2) is derived from a fatty acid having 10 to 16 carbon atoms.

7. The dental patch according to claim 3 to 5,

The average degree of condensation of glycerin of component (xb-2) is 5 to 12.

8. The dental patch according to any one of claim 2 to 5, wherein,

Component (xb) contains at least polyoxyethylene hydrogenated castor oil (xb-1) and polyglycerin fatty acid ester (xb-2), and

The mass ratio (xb-1)/(xb-2) of the content of the component (xb-1) to the content of the component (xb-2) in the innermost adhesion layer (X) is 0.1 to 10.

9. The dental patch according to any one of claim 1 to 5, wherein,

The innermost layer (X) contains 1 or more water-soluble polymers (xd) selected from pullulan, hydroxyethyl cellulose, guar gum, hydroxypropyl cellulose, hypromellose, gelatin, and agar.

10. The dental patch according to any one of claim 1 to 5, wherein,

The component (xa) is 1 or 2 or more selected from phytic acid, pyrophosphoric acid, tripolyphosphoric acid, glycyrrhizic acid, glycyrrhetinic acid and salts thereof, and potassium nitrate, sodium fluoride, potassium fluoride, ammonium fluoride, and sodium monofluorophosphate.

11. The dental patch according to any one of claim 1 to 5, wherein,

The content of the component (xa) is 0.05 mass% or more and 30 mass% or less in 100 mass% of the innermost adhesive layer (X).

12. The dental patch according to claim 3 to 5,

The innermost adhesive layer (X) contains a nonionic surfactant other than the component (xb-1) and the component (xb-2) as the component (xb).

13. The dental patch of claim 12, wherein,

The nonionic surfactant other than the component (xb-1) and the component (xb-2) is 1 or more selected from polyoxyethylene alkyl ether, polyoxyethylene polyoxypropylene copolymer, sucrose fatty acid ester, sorbitan fatty acid ester, glycerin fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene sorbitol fatty acid ester, polyoxyethylene glycerin fatty acid ester, polyoxyethylene glycol fatty acid ester, polyoxyethylene phytosterol and phytostanol, polyoxyethylene lanolin and lanolin, polyoxyethylene alkylamine and fatty acid amide, polyoxyethylene alkylphenyl formaldehyde condensate, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene alkylphenyl ether and fatty acid ethanolamide.

14. The dental patch according to any one of claim 2 to 5, wherein,

The content of the component (xb) is 3 mass% or more and 5 mass% or less in 100 mass% of the innermost layer (X).

15. The dental patch according to claim 3 to 5,

The content of the component (xb-1) is 0.2 to 5.5% by mass based on 100% by mass of the innermost adhesion layer (X).

16. The dental patch according to claim 3 to 5,

The content of the component (xb-2) is 0.1 to 3% by mass based on 100% by mass of the innermost adhesion layer (X).

17. The dental patch according to any one of claim 1 to 5, wherein,

The innermost attachment layer (X) further contains a fragrance (xc).

18. The dental patch of claim 17, wherein,

Component (xc) is selected from: a single fragrance ingredient of menthol, pulegol, carvone, anethole, eucalyptol, methyl salicylate, cinnamaldehyde, eugenol, 3-1-menthoxypropane-1, 2-diol, daphnetinol, citronellyl acetate, linalool acetate, geraniol, geranyl acetate, citronellol, limonene, menthone, menthyl acetate, N-substituted-p-menthane-3-carboxamide, pinene, octanal, citral, pulegone, carvyl acetate, dihydrocarvom acetate, anisaldehyde, benzaldehyde, camphor, ethyl acetate, ethyl butyrate, allyl cyclohexyl propionate, methyl anthranilate, ethyl methyl phenyl glycidate, vanillin, undecanolide, hexanal, butyl acetate, isopentyl acetate, hexenol, dimethyl sulfide, methyl cyclopentenone, furfural, trimethyl pyrazine, ethyl lactate, methyl lactate, ethyl thioacetate; a blended flavor component of strawberry flavor, apple flavor, banana flavor, pineapple flavor, grape flavor, mango flavor, butter flavor, milk flavor, fruit blend flavor, tropical fruit flavor; peppermint oil, spearmint oil, cassiterite oil, anise oil, eucalyptus oil, wintergreen oil, cinnamon oil, clove oil, thyme oil, sage oil, sclareca oil, nutmeg oil, fennel oil, lemon oil, orange oil, peppermint oil, cardamon oil, coriander seed oil, basil oil, tangerine oil, lime oil, lavender oil, rosemary oil, ginger oil, grapefruit oil, bay oil, golden chrysanthemum oil, caraway oil, marjoram oil, geranium oil, lemon grass oil, lemon balm oil, multi-fragrant fruit oil, rose grass oil, rosewood oil, pine needle oil, bitter orange leaf oil, orange flower oil, rose oil, jasmine oil, and one or more of the fragrance components obtained by processing these natural fragrance components.

19. The dental patch of claim 17, wherein,

The content of the component (xc) is 0.1 to 3 mass% in 100 mass% of the innermost adhesive layer (X).

20. The dental patch according to any one of claim 1 to 5, wherein,

The innermost adhesive layer (X) further contains a water-soluble polymer (xd).

21. The dental patch of claim 20, wherein,

The content of the component (xd) is 30 to 70 mass% of the 100 mass% of the innermost adhesive layer (X).

22. The dental patch according to any one of claim 1 to 5, wherein,

The total content of 1 or 2 or more selected from the components (yb) and (yc) is 7 to 90 mass% of the outermost protective layer (Y) in 100 mass%.

23. The dental patch according to any one of claim 1 to 5, wherein,

The water content is 5 to 16 mass% of the innermost adhesive layer (X) in 100 mass%.

24. The dental patch according to any one of claim 1 to 5, wherein,

The outermost protective layer (Y) is a layer that can be removed by brushing with a toothbrush.

25. The dental patch according to any one of claim 1 to 5, wherein,

The content of the surfactant in 100 mass% of the outermost protective layer (Y) is less than 0.1 mass%, or the outermost protective layer (Y) contains no surfactant.

26. The dental patch according to any one of claim 1 to 5, wherein,

The thickness of the outermost protective layer (Y) is 0.1 μm or more and 5 μm or less.

27. The dental patch according to any one of claim 1 to 5, wherein,

The thickness of the innermost adhesive layer (X) is 9.9-95 μm.

28. The dental patch according to any one of claim 1 to 5, wherein,

The total thickness of the dental patch is 10-100 μm.

29. The dental patch according to any one of claim 1 to 5, wherein,

When the dental patch is applied to teeth, the time from immediately after the application to the time when the innermost adhesive layer (X) is completely dissolved in saliva is 3 minutes to 60 minutes.